BLT vs Lidocaine for Procedural Pain

Overseen By Nardin Awad, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: Anxiolytics, Opiates

Disqualifiers: Cardiac/respiratory disease, Seizure disorder, Neuropathies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the effectiveness of a new cream called BLT (a mix of benzocaine, lidocaine, and tetracaine) compared to standard lidocaine cream in reducing pain during skin treatments like IPL, PDL, and microneedling. One cream will be applied to one side of the face and the other cream to the opposite side to assess which provides better pain relief. Individuals who regularly undergo these skin treatments and have no allergies to the creams may be suitable for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking anxiolytics (medications for anxiety) or opiates (pain medications) as they may interfere with the study results.

What is the safety track record for these treatments?

Previous studies have shown that the skin creams Benzocaine, Lidocaine, and Tetracaine (BLT) are generally well-tolerated. People over 17 years old can use them up to three or four times a day, indicating they are quite safe for most individuals. However, benzocaine can be risky for mouth pain, but this risk does not apply to skin use.

Lidocaine alone is also commonly used and generally safe for skin application, providing pain relief during various procedures. Allergic reactions are rare, but using it correctly is crucial to avoid issues.

Overall, both treatments are regularly used and have a history of being safe for the skin. Always follow healthcare providers' instructions to minimize any risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the effectiveness of two topical anesthetics, BLT and Lidocaine, in managing procedural pain. Most treatments for minor procedural pain use Lidocaine due to its proven numbing properties. However, BLT, which combines benzocaine, lidocaine, and tetracaine, might offer a different pain-relief profile. This trial aims to discover whether BLT provides superior or faster pain relief compared to Lidocaine alone, potentially offering a more effective solution for patients.

What evidence suggests that this trial's treatments could be effective for procedural pain?

Research has shown that both BLT cream (containing Benzocaine 20%, Lidocaine 8%, and Tetracaine 4%) and Lidocaine alone effectively reduce pain during procedures. In this trial, participants will receive BLT on one side of the face and Lidocaine on the other to compare their effectiveness. The ingredients in BLT reduce the sensitivity of nerve endings, providing strong relief. Tetracaine, one of the components in BLT, excels at reducing pain. Lidocaine is a well-known cream that numbs the skin and has proven to safely and effectively control pain. Both treatments are effective, but BLT might reduce pain more due to its combination of active ingredients. ^{1 6 7 8 9}

Who Is on the Research Team?

Brian J Simmons, MD

Principal Investigator

Dartmouth Health

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pain during specific skin procedures like IPL (intense pulsed light), PDL (pulsed dye laser), and microneedling. Details on who can join or reasons for exclusion are not provided.

Inclusion Criteria

I regularly see a dermatologist for skin treatments like IPL, PDL, or microneedling.

Exclusion Criteria

I am currently taking anxiety medication or painkillers.

I am currently pregnant or breastfeeding.

I am being treated for a skin condition that could affect this study's evaluation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical anesthetics (BLT and Lidocaine) applied to the face prior to IPL, PDL, and microneedling procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain relief effectiveness immediately after treatment

1 day

What Are the Treatments Tested in This Trial?

Interventions

• BLT
• Lidocaine topical

Trial Overview The study aims to compare the effectiveness of a compounded anesthetic cream called BLT (Benzocaine/Lidocaine/Tetracaine) with a standard 4% Lidocaine cream in reducing pain from certain dermatological procedures.

How Is the Trial Designed?

Group I: Left Side Lidocaine Experimental Treatment 2 Interventions

Subjects will receive topical 4% Lidocaine applied to the left side of the face and 4% BLT applied to the right side of the face prior to treatment.

Group II: Left Side BLT Experimental Treatment 2 Interventions

Subjects will receive topical BLT applied to the left side of the face and 4% Lidocaine applied to the right side of the face prior to treatment.

BLT is already approved in United States, Canada for the following indications:

Approved in United States as BLT for:

• Pain relief during IPL, PDL, and microneedling procedures
• Minor burns and skin irritations
• Minor cuts and scrapes
• Itching

Approved in Canada as BLT for:

• Pain relief during IPL, PDL, and microneedling procedures
• Minor burns and skin irritations
• Minor cuts and scrapes
• Itching

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

In a study involving 44 children aged 4 to 10, lignocaine gel was found to have lower pain scores compared to benzocaine gel when used as a topical anesthetic before local anesthesia, although the differences were not statistically significant.

Both lignocaine and benzocaine were equally effective as topical anesthetics, but children preferred the taste of lignocaine over benzocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Two Different Topical Anesthetic Agents in Controlling Pain during Intraoral Local Anesthetic Administration in Children: A Split-mouth Triple-blinded Randomized Clinical Trial. Kotian, N., Mani, G., Ramakrishnan, M.[2022]

Compound topical anesthetics, while potentially effective for dental procedures, are not FDA-regulated, raising significant safety concerns due to the risk of adverse reactions, including two reported deaths.

The FDA is increasing efforts to regulate these anesthetics, as some compounding pharmacies bypass the approval process, which ensures drugs are safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of compound topical anesthetics: a review. Kravitz, ND.[2019]

In a study involving 40 subjects undergoing superficial dermatosurgical procedures, the combination cream of 7% lignocaine and 7% tetracaine provided significantly better pain relief compared to the 2.5% lidocaine and 2.5% prilocaine cream, as measured by visual analogue scale scores.

The findings suggest that the lignocaine/tetracaine combination is an effective topical anesthetic for short-term use (30 minutes), allowing for quicker onset of analgesia and potentially improving the efficiency of dermatological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. Gahalaut, P., Mishra, N., Chauhan, S., et al.[2021]

A study involving 8 healthy volunteers found that using 30 or 60 grams of occluded topical liposomal lidocaine (LMX4) for pain control in cosmetic procedures resulted in no significant absorption of lidocaine or its metabolites, indicating safety in these amounts.

Participants reported no systemic effects or clinical signs of lidocaine toxicity, supporting the conclusion that moderate use of 4% lidocaine cream is safe for dermatologic and cosmetic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of occluded 4% liposomal lidocaine cream. Nestor, MS.[2013]

The FDA-approved lidocaine and tetracaine topical anesthetic cream (Pliaglis®) is both safe and effective for managing pain during various dermatologic laser procedures, including laser resurfacing and hair removal.

Dermatologists should consider using LT cream as a preferred option for topical anesthesia to enhance patient comfort and satisfaction during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management with a topical lidocaine and tetracaine 7%/7% cream with laser dermatologic procedures. Cohen, JL.[2013]

Lidocaine/tetracaine cream (Pliaglis) is a newer topical anesthetic that effectively reduces pain during cosmetic dermatologic procedures, as shown in multiple clinical trials.

This combination anesthetic is favored for its ease of use and mild side effects compared to other topical anesthetics, making it a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. Alster, T.[2021]

In a study involving children aged 1-15 years, lidocaine-prilocaine cream was found to be significantly more effective than tetracaine 4% cream for pain relief during venipuncture, with 97% of patients receiving lidocaine-prilocaine reporting adequate pain relief compared to 76% for tetracaine.

Despite the statistical superiority of lidocaine-prilocaine, the clinical significance of the difference is minor, and tetracaine offers practical advantages such as a shorter application time, vasodilation effects, and lower cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetracaine versus lidocaine-prilocaine for preventing venipuncture-induced pain in children. van Kan, HJ., Egberts, AC., Rijnvos, WP., et al.[2019]

A study involving 50 subjects with actinic keratosis showed that a self-occlusive topical anesthetic cream (7% lidocaine/7% tetracaine) significantly reduced pain during conventional photodynamic therapy (cPDT), with a 47% decrease in pain scores compared to a vehicle cream.

The lidocaine-tetracaine cream resulted in a median pain score reduction of 60%, demonstrating its effectiveness in making the cPDT procedure more tolerable for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The "3P-Trial"). Brumana, MB., Milani, M., Puviani, M.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7083119/

Comparing the Efficacy of a Compound Topical Anesthetic ... Conclusion. In summary, a CTA comprised of 10% lidocaine, 10% prilocaine, and 4% tetracaine was less effective than 20% benzocaine at reducing pain associated ...

2. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/comparative-evaluation-of-the-efficacy-of-different-topical-anesthetic-agents-in-cosmetic-surgical-procedures-an-original-research-2887/

Comparative Evaluation of the Efficacy of Different Topical ... Patients reported the lowest pain scores with Tetracaine. Conclusion: Tetracaine was the most effective anesthetic in terms of pain reduction and duration, ...

3. nature.com nature.com/articles/s41405-024-00275-8

Efficacy of topical anesthetics of lidocaine, benzocaine ... This study aimed to evaluate the efficacy of 5% EMLA cream and 8% lidocaine gel in reducing pain during inferior alveolar nerve block (IANB) compared with 20% ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5404778/

Comparative Study of Compounded Anesthetic ... Results: The study found a statistically significant difference (P<0.05) in the mean pain level as measured by the VAS and Wong-Baker Faces Pain Rating Scale ...

5. transcarebc.ca transcarebc.ca/sites/default/files/2024-03/BLT_Info_Sheet_for_Patients_2021_03_26.pdf

Benzocaine, Lidocaine & Tetracaine or ... The ingredients in BLT and LT cause the nerve endings in the treated area to be less responsive to pain signals while the product is working. ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/lidocaine-and-tetracaine-topical-application-route/description/drg-20072742

Lidocaine and tetracaine (topical application route) This medicine does not cause unconsciousness as general anesthetics do when used for surgery. This medicine is available only with your doctor's prescription.

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9dc5db9d-9e0a-cd28-e053-2995a90a6bf7

BLT SKIN CREAM- benzocaine, lidocaine, tetracaine cream Safety. Report Adverse Events · FDA Safety ... Adults and children over 17 years of age: Apply to affected area of pain no more than 3-4 times per day.

8. drugs.com drugs.com/pro/lidocaine-and-tetracaine-cream.html

Lidocaine and Tetracaine Cream: Package Insert / ... Lidocaine and tetracaine cream has been evaluated for safety in 2159 persons undergoing a superficial dermal procedure. Lidocaine and tetracaine cream was ...

9. fda.gov fda.gov/drugs/drug-safety-and-availability/risk-serious-and-potentially-fatal-blood-disorder-prompts-fda-action-oral-over-counter-benzocaine

Risk of serious and potentially fatal blood disorder prompts ... These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething.